Reducing Stasis Outcomes for Depression in Group Behavioural Activation Therapy

NCT02970279 | Completed

• 1 other identifier: Protocol Version 3.0
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is one of the most common mental health disorders and it is estimated up to 50% of patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis' outcome. However, there is limited research understanding this population, meaning a considerable number of people continue to suffer. The purpose of this study is to 1) identify depression stasis prevalence and predictors in an existing evidenced-based group treatment for depression, 2) run a clinical trial to test whether an embedded intervention based on theoretical and clinical practice evidence can help reduce patient depression stasis and drop-out rates and 3) understand what aspect of therapy produces change (or prevents change in stasis). The study will be based on behavioural activation (BA) therapy delivered in an eight-session group format in an Improving Access to Psychological Therapies (IAPT) service in the United Kingdom. BA is one of the most effective psychotherapies available for depression and focuses on helping patients to increase their engagement with valued activities to help break out of the cycle of depression. Firstly, an archived anonymised dataset of routine depression measures from patients who have previously received the existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to patients in 2017 will be enhanced with two treatment augmentations. One augmentation will target stasis outcomes through the addition of specific 'if-then' planning (known as implementation intentions) when setting between-session homework and the other augmentation will target patient drop-out by informing patients about group BA effectiveness and therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in the trial will be compared with the archived outcomes to see if the intervention has had an effect and the role of engaging in valued living as a mechanism of change for depression symptoms will be examined. It is hypothesised that a) 50% of patients who have received the existing BA group treatment for depression will have a stasis outcome, b) there will be a significant reduction in depression stasis outcomes and drop-out rate following the enhanced BA group treatment delivered in the trial and c) engagement in valued living will have a mediating effect on outcome for responding patients following the enhanced BA group treatment but the effect will not be present for patients with a stasis outcome.

Conditions

Depression

Keywords

Behavioural activation; Psychotherapy, group; Depression; Depressive disorder

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire (PHQ-9) scores

  Validated 9-item self-report measure of depressive symptoms

  Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)

Secondary Outcomes (4)

• Patient attendance at treatment sessions

  Weeks 1-8 (every weekly treatment session - maximum of 8)

• Change in Valued Living Questionnaire (VLQ) score

  Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment)

• Change in Generalised Anxiety Disorder Assessment (GAD-7) score

  Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)

• Change in Work and Social Adjustment Scale (WSAS) score

  Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)

Other Outcomes (1)

• Behavioural activation group (BAG) therapy adherence

  Weeks 1-8 (Every treatment session)

Study Arms (1)

Enhanced Behavioural Activation Groups

EXPERIMENTAL

Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations; 1. Implementation intentions 2. Dose-response psychoeducation

Behavioral: Behavioural Activation Group (BAG) Psychotherapy

Interventions

Behavioural Activation Group (BAG) Psychotherapy BEHAVIORAL

Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.

Enhanced Behavioural Activation Groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who access the Sheffield Improving Access to Psychological Therapies (IAPT) service (United Kingdom) with depression as the primary presenting problem
• Patients with co-morbid anxiety symptoms can be included as long as depression is the primary diagnosis
• Are referred to and choose the Behavioural Activation Group (BAG) treatment option
• Able to attend the BAG intervention
• Aged 18 or over

You may not qualify if:

• Primary diagnosis that is not depression
• Patients who do not choose BAG as a treatment option
• Aged under 18

Sponsors & Collaborators

• University of Sheffield: lead
• Sheffield Health and Social Care NHS Foundation Trust: collaborator
• Howard Morton Trust: collaborator

Study Sites (1)

Sheffield Health and Social Care NHS Foundation Trust - Improving Access to Psychological Therapies Service

Sheffield, South Yorkshire, S3 7ND, United Kingdom

Location

Related Publications (1)

• Gollwitzer, P. M. (1999). Implementation intentions: Strong effects of simple plans. American Psychologist, 54, 493-503.

  BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Melanie K Simmonds-Buckley, BSc

  University of Sheffield

  PRINCIPAL INVESTIGATOR

• Stephen Kellett, DClinPsy

  University of Sheffield & Sheffield Health and Social Care NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Glenn Waller, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Student

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 21, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)